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Biosecurity at CDC pre & post 9/11

Biosecurity at CDC pre & post 9/11. Jonathan Y. Richmond, PhD Director Office of Health and Safety CDC, Atlanta. A Bit of History. 1994: Tokyo, Sarin and biological attacks 1995: Larry Wayne Harris Select Agent program (1997) 1995: pre-Olympics security evaluation caused change

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Biosecurity at CDC pre & post 9/11

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  1. Biosecurity at CDCpre & post 9/11 Jonathan Y. Richmond, PhD Director Office of Health and Safety CDC, Atlanta

  2. A Bit of History • 1994: Tokyo, Sarin and biological attacks • 1995: Larry Wayne Harris • Select Agent program (1997) • 1995: pre-Olympics security evaluation caused change • “open” to “somewhat closed” campus • 1997: Oklahoma City bombing • COOP requirement

  3. Prior to the Select Agent Rule • No uniform identification of facilities working with human pathogens • No mandated safety requirements for handling these agents • No tracking and verification of the transfer of these agents

  4. Appendix A To Part 72 - Select Agents Select Agent Rule, 1997 13 Viruses 9 Bacteria 3 Rickettsiae 1 Fungi 12 Toxins Genetically modified / genetic elements

  5. BMBL, 4th edition, 1999

  6. BioSecurity considerations for • Laboratories using biological agents or toxins capable of causing serious or fatal illness to humans or animals, and to … • Minimize opportunities for accidental or intentional removal of these agents from the laboratory.

  7. Risk Assessments Why me? People, facilities, data, product, animals, microbes …

  8. Lab security is related to but different than lab safety • Involve safety and security experts in facility evaluation and development of recommendations • Review safety/security policies regularly and following an incident or threat

  9. Emergency planning • Needs to be integrated throughout the organization & cover all contingencies • Evacuation & accountability • Physical events (fire, power, bombs, …) • Natural events (storms, earthquakes, …) • Breaches of containment • Requires a 2-tiered approach • Strategic • Tactical

  10. Critical Biological Agents Category A • Bacillus anthracis (Anthrax) • Yersinia pestis (Plague) • Franciscella tularensis (Tularemia) • Hemorrhagic fever viruses (Ebola, Marburg) • Clostridium botulinum toxin (Botulism) • Variola major (Smallpox)

  11. Adding Physical Barriers “Hardening” access

  12. Physical barriers

  13. Vehicular Control

  14. Personnel Monitoring

  15. Accountability • Know what you have (inventory). • Know where it is. • Know who has access to it. • Know who gets it. • Know when it is destroyed or transferred. • “Knowing” means a written record.

  16. Control access to where agents are stored & used • Labs & animal areas separated from public areas locked at all times • Card-key or other controlled access • Visitor entry recorded; restricted to times when staff are available for escort • Lock storage rooms, cabinets, freezers containing agents

  17. Controlling access

  18. Know your workers • Depending on the agents involved, background checks &/or security clearances should be done before workers are given access w/o escort. • Provide appropriate training & establish record base before issuing access authority.

  19. Change the culture –challenge who is there • All workers wear photo ID badges with name & expiration date. • Use color coding to indicate clearance to enter restricted areas. • Guests are issued Visitor ID badges & are escorted by workers.

  20. Consider lockboxes

  21. Know materials brought into labs & animal facilities • Only accept packages you expect. • Screen all packages (visually, x-ray) before transfer into lab. • Open all packages containing toxins &/or microbiologic agents in safety cabinets or fume hoods.

  22. Centralized Receiving

  23. Mail scanning

  24. Know materials removed for intra-facility transfer • Transport in leak-proof carriers. • Maintain appropriate records regarding transfer. • Contaminated or possibly contaminated materials (waste, equipment) should be decontaminated before removal from lab.

  25. Typical transport carrier

  26. Know materials removed for transfer to distant labs • Microbes &/or toxins shipped to other labs must be packaged & transported in accordance with applicable regs. • Obtain permits as needed (PHS, DOT, DOC, USDA) for shipment. • Keep appropriate records.

  27. Have an emergency plan • Controlling access to labs &/or animal facilities complicates emergency response. • Develop plan before the emergency • Involve all appropriate parties in planning • Inform community-based responders • Conduct drills & after-incident reviews

  28. Have a protocol for reporting & investigating incidents • Report chain to Management, PR, Security, Biosafety • Who investigates incidents? • Unaccompanied visitors • Missing agents • Potential break-ins • Who decides what happens next?

  29. What’s Pending? • Registration if you possess a S/A • Restrictions on clinical exemptions • USA Patriot Act: restricted persons • Expanding penalties for violation • Exempts CDC from FOIA requests

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